Method and device of detecting and/or blocking reflux

ABSTRACT

A naso/orogastric device having backflow blocking means and comprises a naso/orogastric tube sized and shaped for being disposed within the esophagus so that at least a distal end thereof being placed in the stomach lumen of a patient, at least one elastic esophageal body, positioned along the naso/orogastric tube, having a pressure dependent volume, at least one esophageal sensor that detects fluid around at least one segment of the naso/orogastric tube, and a pressure regulator that regulates a pressure within the elastic esophageal body according to the detection.

RELATED APPLICATIONS

This application is a National Phase of PCT Patent Application No.PCT/IL2011/000099 having International filing date of Jan. 27, 2011,which claims the benefit of priority under 35 USC §119(e) of U.S.Provisional Patent Application No. 61/298,945 filed on Jan. 28, 2010.The contents of the above applications are all incorporated by referenceas if fully set forth herein in their entirety.

FIELD AND BACKGROUND OF THE INVENTION

The present invention, in some embodiments thereof, relates to systemand method of detecting reflux and, more particularly, but notexclusively, to system and method of detecting reflux when anaso/orogastric tube if placed in esophagus and stomach.

Naso/orogastric feeding, such as esophageal, gastric, duodenal and/orenteral feeding is a form of alimentation and/or metabolic support inwhich nutrient formulas or medicaments are delivered directly to thegastrointestinal tract, either the stomach or the duodenum. In themajority of cases, nutrient administration is accomplished through useof a tube based device or system, delivering the nutrient through thepatient's pharynx and esophagus directly into the stomach, the duodenumor small intestinum (jejunum). One of the difficulties ofnaso/orogastric feeding is the increased occurrence of reflux-stomachcontents going up to the pharynx of the patient.

A common preventive measure against reflux of stomach contents has beento elevate the patient's upper body into a semi-recumbent position(approximately 45°), thereby reducing the ascension of gastric materialup the esophagus into the pharynx and lungs.

A number of naso/orogastric tubes have been developed to operate anesophageal balloon seal against gastroesophageal contents ascending fromthe stomach into the pharynx. For example, U.S. Pat. No. 4,384,584,filed on Oct. 28, 1981 describes a naso-esophageal catheter is providedwith an inflatable balloon at its distal end and a signal-emittingdevice is located within the balloon so that the location of the distalend of the catheter can be determined when it is advanced into thepatient's esophagus. After the catheter has been advanced into thepatient's esophagus, the balloon is inflated. Thereafter, atrans-cervical esophageal catheter is directed through the patient'sneck towards the center of the inflated balloon. After the balloon hasbeen punctured the naso-esophageal catheter is withdrawn and the patientcan then be fed with liquid nutrients through the trans-cervicalesophageal catheter.

Another example is described in U.S. Patent Application, PublicationNumber 2009/0062725, filed on Aug. 29, 2007 describes an enteral feedingunit that reduces the occurrence of gastroesophogeal-pharynegal refluxduring feeding includes an automatable feeding pump with a feedbacksensor for sensing a relative pressure in a patient's stomach andesophagus, and a regulator system for controlling and monitoring feedingrate to the patient as a function of the relative gastro-esophagealpressure. The system includes a stomach probe that provides afluid-tight closure of the esophagus. The stomach probe includes atampon-bladder for watertight closure of the esophagus, in which thetampon-bladder is formed of flexible and/or elastic material. At leastan inner cavity of the bladder is provided for the reception of a fluidmedium. A prescribed pressure for the medium in the tampon-bladder ismaintained by an inner lumen forming the stomach probe, from which anouter hose-like lumen extending to the tampon bladder is so arrangedthat between the outer lumen and the inner lumen a channel is formedconnected to the inner cavity of the tampon-bladder arranged on theouter lumen by a number of openings. The inner cavity of thetampon-bladder is connected via a canal formed between the inner andouter lumina with a suitably graded reservoir or equalizing vessel forthe liquid medium situated above the tampon-bladder and outside thepatient.

SUMMARY OF THE INVENTION

According to some embodiments of the present invention there is provideda naso/orogastric device having backflow blocking means. Thenaso/orogastric device comprises a naso/orogastric tube sized and shapedfor being disposed within the esophagus so that at least a distal endthereof being placed in the stomach lumen of a patient, at least oneelastic esophageal body, positioned along the naso/orogastric tube,having a pressure dependent volume, at least one esophageal sensor thatdetects fluid around at least one segment of the naso/orogastric tube,and a pressure regulator that regulates a pressure within the at leastone elastic esophageal body according to the detection.

Optionally, the at least one esophageal sensor comprises at least oneimpedance sensor for sensing an impedance change around at least onesegment of the naso/orogastric tube.

Optionally, the naso/orogastric tube have distal and proximal ends, theat least one esophageal sensor comprises a first esophageal sensor inproximity to the distal end and a second esophageal sensor between thedistal end and the proximal end.

More optionally, the pressure regulator regulates the pressure accordingto difference between a first reading of the first esophageal sensor anda second reading of the second esophageal sensor.

More optionally, the first and second readings are impedance changereadings.

More optionally, the pressure regulator regulates the pressure accordingto the timing of a first detection event of the first reading relativeto a second detection event of the second reading.

More optionally, the at least one esophageal sensor comprises at leastone impedance sensor for detecting low impedance around the at least onesegment.

More optionally, the impedance change is indicative of a content offluid around the at least one esophageal sensor.

Optionally, the naso/orogastric device further comprises an airconducting tube having a lumen for allowing the pressure regulator tochange the pressure in the at least one elastic esophageal body, the airconducting tube being attached to a peripheral surface of the tube.

More optionally, the air conducting tube is made of a layer ofbiocompatible flexible polymer having a thickness of less than 200micron.

Optionally, the tube has a first lumen for delivering nutrients,microorganisms, water or medications into the stomach lumen and a secondlumen for at least one of inflating and deflating the at least oneelastic esophageal body.

More optionally, each the impedance sensor comprises a plurality ofelectrodes arranged in a circular fashion around the naso/orogastrictube.

Optionally, the naso/orogastric device further comprises a pumpassembly, controlled by the pressure regulator so as to regulate thepressure by inflating the at least one elastic esophageal body.

More optionally, the pump assembly comprising an air pressure tank, thepump assembly increases the air pressure in the air pressure tank so asto expedite the inflation.

More optionally, the at least one elastic esophageal body comprises aplurality of balloons arranged one after the other along thenaso/orogastric tube.

Optionally, the naso/orogastric device further comprises at least onepositioning sensor and a controller that detects a location of at leastone portion of the naso/orogastric tube in the esophagus.

More optionally, the at least one positioning sensor comprises a wirethreaded in a channel along the naso/orogastric tube, the channel havingat least one opening therealong.

More optionally, a pressure assembly regulates the pressure according tothe location.

More optionally, the controller detects a movement according to a changein the location; the pressure regulator reducing the pressure inresponse to the change.

Optionally, the naso/orogastric device further comprises a connection toa cable having a filter to adjust air flow from the pressure regulator.

Optionally, the at least one esophageal sensor comprises a plurality ofwires threaded in a plurality of channels along the naso/orogastrictube, each the channel having at least one opening therealong.

According to some embodiments of the present invention there is provideda method of preventing reflux during at least one of tube feeding andesophageal endoscopy of patient. The method comprises disposing anaso/orogastric tube having at least one elastic esophageal body withinthe esophagus so that at least a distal end thereof being placed in thestomach lumen of a patient and the at least one elastic esophageal bodybeing placed along a segment of esophagus, detecting fluid in at leastone region along esophagus in at least position around thenaso/orogastric tube, between the segment and the stomach, andregulating a pressure within the at least one elastic esophageal bodyaccording to the detection.

Optionally, the detecting comprises sensing an impedance change in theat least one region.

More optionally the regulating comprises increasing the pressure so asto block the esophagus when the impedance is indicative of present ofgastric content in the at least position.

More optionally the regulating comprises decreasing the pressure whenthe impedance is indicative of an absence of gastric content in the atleast position.

Optionally, the disposing comprises disposing an elastic stomach bodywithin the stomach, around the distal end, the regulating comprisesregulating an additional pressure within the elastic stomach body inparallel and in correspondence with the pressure so as to prevent fromthe at least one elastic esophageal body from moving toward the pharynxof the patient.

According to some embodiments of the present invention there is provideda naso/orogastric device having backflow blocking means that comprises anaso/orogastric tube having a lumen for delivering content into thestomach lumen of a patient, at least one backflow blocking meanspositioned along the naso/orogastric tube and a having at least one of aperimeter wider than the perimeter of the naso/orogastric tube and anadjustable structure having at least one state wider than the perimeterof the naso/orogastric tube, and an elastic stomach body at a distal endof the naso/orogastric tube and configured for being inflated by thecontent so as to have a perimeter wider than the perimeter of the loweresophageal sphincter of the patient.

Optionally, the content comprises a member of a group consisting of:nutrients, microorganisms, water and medications.

Unless otherwise defined, all technical and/or scientific terms usedherein have the same meaning as commonly understood by one of ordinaryskill in the art to which the invention pertains. Although methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of embodiments of the invention, exemplarymethods and/or materials are described below. In case of conflict, thepatent specification, including definitions, will control. In addition,the materials, methods, and examples are illustrative only and are notintended to be necessarily limiting.

BRIEF DESCRIPTION OF THE DRAWINGS

Some embodiments of the invention are herein described, by way ofexample only, with reference to the accompanying drawings. With specificreference now to the drawings in detail, it is stressed that theparticulars shown are by way of example and for purposes of illustrativediscussion of embodiments of the invention. In this regard, thedescription taken with the drawings makes apparent to those skilled inthe art how embodiments of the invention may be practiced.

In the drawings:

FIG. 1 is a schematic illustration of a portion of a naso/orogastrictube having one or more fluid sensors for detecting a reflux and acontrollable reflux blocking device for blocking GI contents, accordingto some embodiments of the present invention;

FIGS. 2A-2C are exemplary electrodes of exemplary impedance sensors,according to some embodiments of the present invention;

FIG. 2D is a schematic illustration of a portion of a naso/orogastrictube having a plurality of balloons for blocking backflow, according tosome embodiments of the present invention;

FIG. 3 is a flowchart of a method of blocking reflux when anaso/orogastric device is temporary disposed in the esophagus, accordingto some embodiments of the present invention;

FIG. 4 is a flowchart of a method of blocking reflux when anaso/orogastric device is temporary disposed in the esophagus, accordingto some embodiments of the present invention;

FIG. 5, which is a schematic illustration of an exemplary pump assembly,according to some embodiments of the present invention;

FIG. 6 is a schematic illustration of a portion of the naso/orogastricdevice depicted in FIG. 1, where an elastic stomach body 701 is attachedto the distal end of its naso/orogastric tube, according to someembodiments of the present invention 101; and

FIG. 7 is a schematic illustration of a portion of a naso/orogastrictube having an external air conducting tube for inflating an elasticesophageal body thereof, according to some embodiments of the presentinvention;

FIG. 8 is a schematic illustration of a naso/orogastric device, such asthe naso/orogastric device depicted in FIG. 1, where one or morepositioning sensors are placed along the naso/orogastric tube of thedevice, according to some embodiments of the present invention;

FIG. 9A is a cross sectional illustration of an exemplarynaso/orogastric tube, according to some embodiments of the presentinvention;

FIG. 9B is a cross sectional illustration of an exemplarynaso/orogastric tube, with exemplary dimensions, according to someembodiments of the present invention;

FIGS. 9C and 9D are exemplary openings for allowing a fluid sensor and apositioning sensor to function, according to some embodiments of thepresent; and

FIGS. 10A and 10B are schematic illustrations of an exemplary connectorthat allows connecting a naso/orogastric tube to a feeding device, apump assembly and a controller, according to some embodiments of thepresent invention.

DESCRIPTION OF EMBODIMENTS OF THE INVENTION

The present invention, in some embodiments thereof, relates to systemand method of detecting reflux and, more particularly, but notexclusively, to system and method of detecting reflux when anaso/orogastric tube if placed in esophagus and stomach.

According to some embodiments of the present invention there is provideda naso/orogastric device having backflow blocking means which areoperated according to the detection of fluids in the esophagus and oraround the Lower Esophageal Sphincter (LES), for example using impedancesensors. The naso/orogastric device includes a naso/orogastric tubesized and shaped for being disposed within the esophagus so that atleast a distal end thereof is placed in the stomach lumen of a patient.Such a naso/orogastric tube may be used for tube feeding and/oresophageal endoscopy. The naso/orogastric device further includes one ormore esophageal elastic bodies, such as balloons which are positionedalong the naso/orogastric tube and have a pressure dependent volume andone or more esophageal and or LES sensors that detect, in use, fluidsaround segments of the naso/orogastric tube in the esophagus and or LES.The fluid sensors are connected to a pressure regulator that regulatesthe pressure within the elastic esophageal body according to thedetection of fluid. For example, the pressure regulator operates a pumpassembly according to the detection.

Optionally, the fluid sensors are impedance sensors each includes one ormore electrodes, such as annular electrodes, helical electrodes, and/orstrip electrodes.

According to some embodiments of the present invention, there isprovided a naso/orogastric device having naso/orogastric tube andbackflow blocking means, such as a balloon, which is connected to aflexible air conducting tube attached to the peripheral surface of thenaso/orogastric tube. Optionally, the conducting tube is part of aflexible sheath covering the naso/orogastric tube. The flexible sheathhas a thickness of between about 50 and about 150 micron and designed toshriek on to the peripheral surface of the naso/orogastric tube thus notcausing further discomfort to the patient when passing through thenasopharynx. As the flexible air conducting tube is widen only whenbeing used for inflating the backflow blocking means and as theperimeter of the naso/orogastric tube can be reduced as an outcome ofthe extraction of the flexible air conducting tube from its inner lumen,such a naso/orogastric device apply less pressure on the esophagus'swalls when disposed therein than a naso/orogastric device in which theair conducting tube in placed in the inner lumen. When using such aflexible sheath side effects of using a large bore tube, for examplediscomfort is avoided.

According to some embodiments of the present invention there is provideda naso/orogastric device having backflow blocking means and an elasticstomach body which is designed to be inflated in the stomach so as toprevent the sliding of the backflow blocking means toward the pharynx.The naso/orogastric device has a naso/orogastric tube having a lumen fordelivering content, such as nutrients, microorganisms, water and/ormedications, into the stomach lumen of a patient, a backflow blockingmeans, such as one or more balloons positioned along the naso/orogastrictube and a having a perimeter wider than the perimeter of thenaso/orogastric tube or an adjustable structure having a state widerthan the perimeter of the naso/orogastric tube. The naso/orogastricdevice further includes an elastic stomach body having a pressuredependent volume at a distal end of the naso/orogastric tube.Optionally, the elastic stomach body is inflated by the deliveredcontent so as to have a perimeter wider than the perimeter of the loweresophageal sphincter of the patient. In such a manner, thenaso/orogastric tube does not slide outward the body of patient andtherefore does not elevate the backflow blocking means toward thepharynx.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not necessarily limited in itsapplication to the details of construction and the arrangement of thecomponents and/or methods set forth in the following description and/orillustrated in the drawings and/or the Examples. The invention iscapable of other embodiments or of being practiced or carried out invarious ways.

Reference is now made to FIG. 1, which is a schematic illustration of aportion of a naso/orogastric device 100 having a naso/orogastric tube101 one or more fluid sensors 102 for detecting a reflux of GI contents,which may be referred to herein as backflow, and a controllable refluxblocking device 103 for blocking GI contents, according to someembodiments of the present invention.

The naso/orogastric device 100 includes a naso/orogastric tube 101having an inner lumen (not shown) for delivering nutrients,microorganisms, water and/or medications. The naso/orogastric tube 101is defined herein as any commonly used naso/orogastric tube, for examplea naso/orogastric feeding tube, a naso-esophageal catheter, a gastricfeeding tube, such as a nasogastric feeding tube, a duodenal feedingtube and an enteral feeding tube. The naso/orogastric tube 101 is sizedand shaped for being disposed within the esophagus so that a distal endthereof is placed in the stomach lumen of a patient. Optionally, thenaso/orogastric tube 101 comprises a small diameter flexible tubepreferably made of transparent plastic, such as polyvinyl Chloride orsilicone. The length of the naso/orogastric tube 101 is adjusted to thesize of the patient. For example, a naso/orogastric device for adultpatients has a naso/orogastric tube 101 of more than 120 centimeter longfor 18 Fr tube and a naso/orogastric device for infants has anaso/orogastric tube 101 of more than 40 centimeter long for 5 Fr tube.

As outlined above, the naso/orogastric device 100 further comprises oneor more fluid sensors 102 for detecting at least the presence or absenceof fluids, such as impedance sensors and/or optical sensors, along thenaso/orogastric tube 101. In use, when placed in the esophagus, thefluid sensors 102 detect presence or absence of a gastric contentsbackflow, for example as described below.

The controllable reflux blocking device 103 includes one or moreesophageal elastic bodies such as balloon catheters, which arepositioned along the naso/orogastric tube and has a pressure dependentvolume. For brevity, the one or more esophageal elastic bodies arereferred to herein as an elastic esophageal body 103. The elasticesophageal body 103 is connected to a distal end of an air conductingtube 104 that allows inflating the elastic esophageal body 103. Theproximal end of the air conducting tube 104 is optionally connected to apump assembly 105 that inflates the elastic esophageal body 103.Optionally, the elastic esophageal body 103, which is connected to theconducting tube, is connected to pressure tank that releases thepressure in high speed, using controller 106, and inflate the balloon inhigh speed, for example as further described below. Optionally, theelastic esophageal body 103 is connected to another air conducting tubethat allows deflating the elastic esophageal body 103. Optionally, thepump assembly 105 is a bidirectional pump that allows inflating anddeflating the elastic esophageal body 103.

The one or more fluid sensors 102 and the pump assembly 105 areconnected to a controller 106. The controller 106, which may include apressure regulator module, operates the pump assembly 105 according tothe reading of the fluid sensors 102.

As described above the fluid sensors 102 may be impedance sensors 102.Optionally, each impedance sensors 102 includes one or more electrodesthat encircle the naso/orogastric tube 101. Optionally, each impedancesensor 102 includes one or more annular or helical electrodes, forexample as shown at FIGS. 2A and 2B.

Optionally, each impedance sensors 102 includes a plurality of parallelstrip electrodes which are circularly and dividedly placed around acommon segment of the naso/orogastric tube 101, for example as shown atFIG. 2C. Optionally, each electrode covers an area of about 1 mm² and150 mm² Optionally, between 2 and 20 electrodes are used in eachimpedance sensor 102. Optionally, the distance between each pair ofparallel electrodes is between about 3 mm and about 30 mm.

Optionally, the electrode is made of steel, stainless steel, brass,copper, platinum, silver, gold, aluminum alloy, zinc, nickel, tin,magnesium alloy, bronze, phosphor bronze, conductive polymers and/or anycomposition thereof and/or any alloy therefrom.

Optionally, the electrodes are printed on the peripheral surface of thenaso/orogastric tube 101. Optionally, the electrodes are coated withGold, Silver, Nickel, Zinc, Tin, Copper and/or any composition thereofand/or any alloy therefrom.

Optionally, the electrodes are shaped as Circular, rectangular, and/ortriangular spots.

Optionally, one or more of the fluid sensors 102 are placed so as todetect fluid in the stomach, for example in proximity to the loweresophageal sphincter. In such a manner, reflux may be detected evenbefore the GI contents arrive at the esophagus.

Optionally, as outlined above and depicted in FIG. 2D, the elasticesophageal body 103 includes several balloons. In such a manner, theballoons may be in a lower pressure, placing lower pressure on theesophagus. If the GI contents pass the first balloon they are stopped bythe second balloon. The space between the balloons traps the gastriccontent backflow without applying substantial pressure on the esophagealwalls.

Reference is now also made to FIG. 3, which is a flowchart of a methodof blocking reflux when a naso/orogastric device is temporary disposedin the esophagus, according to some embodiments of the presentinvention.

First, as shown at 201, a naso/orogastric tube with an elasticesophageal body, such as shown at 101, 103, is disposed in the esophagusso that at least a distal end thereof is in the stomach lumen of apatient and the elastic esophageal body is placed in a certain segmentof esophagus. In such a manner, the naso/orogastric tube may be used fordelivering nutrients, microorganisms, water and/or medications, asoutlined above.

Now, as shown at 202, the presence or the absence of GI contents in theesophagus is sensed, for example by the one or more fluid sensors 102.Optionally, the fluid sensors 102 are impedance sensors that sense animpedance change in at least one region along esophagus, in a around thenaso/orogastric tube 101, between the stomach and the elastic esophagealbody 103. The detection of GI contents in the esophagus, for example thedetection of impedance change, is indicative of GI contents backflow.The measurements of the fluid sensors 102 are forwarded to thecontroller 106.

As shown at 203, the controller 106 regulates the pressure within theelastic esophageal body 103 according to the detected gastric content inthe esophagus, for example according to a detected impedance change.

Optionally, the pressure regulator module performs such regulation toallow inflating the elastic esophageal body 103 in response to thedetection of gastric contents in the esophagus and/or surrounding theLES. Optionally, the elastic esophageal body 103 is maintained in lowpressure when gastric contents are not detected in the esophagus. Insuch a manner, no redundant pressure is applied on the esophageal wallswhile the naso/orogastric device 100 is used for feeding and/ordiagnosing the patient. By avoiding the appliance of redundant pressureon the esophageal walls, Esophageal ulcer and other disorders may beavoided.

According to some embodiments of the present invention, the one or morefluid sensors 102 detect the direction of fluids in the esophagus. Forexample, the controller 106 may regulate the pressure using its pressureregulator in the elastic esophageal body 103 according to the timing ofa first detection event, such as a detection of a first impedance changeby a first fluid sensor 102 relative to a second detection event, suchas a detection of a second impedance change by a second fluid sensor102. If the first fluid sensor is closer to the stomach than the secondfluid sensor and optionally time between the first and the seconddetection events is in a predefined range, the reading of the fluidsensors 102 are indicative of the direction of fluids in the esophagus.

According to some embodiments of the present invention, the controller106 analyses the content of fluid according to the measurements of thefluid sensors 102. For example, different impedance may be indicative ofdifferent compositions of the fluid around the fluid sensors 102. Forexample, while one impedance value and/or range of impedance values isindicative of saliva, another impedance value and/or range of impedancevalues is indicative of gastric content. For example, while gastriccontent has a high conductivity and respectively low impedance, air hasa low conductivity and respectively high impedance.

Reference is now also made to FIG. 4, which is a flowchart of a methodof blocking reflux when a naso/orogastric device is temporary disposedin the esophagus, according to some embodiments of the presentinvention. Blocks 201-203 are as depicted in FIG. 3. However, a numberof additional operations are depicted in FIG. 4.

Optionally, as shown at 301, after the naso/orogastric tube 101 isdisposed in the esophagus, the elastic esophageal body 103 is partlyinflated, for example about three quarters at a predetermined value.Optionally, the pump assembly 105 is used for inflating the elasticesophageal body 103. Optionally, the inflation is performed until aminor pressure, for example between about 10 mmHg (Torr) and about 40mmHg is detected by a pressure sensor, for example pressure sensor 402in FIG. 5.

Optionally, the minimum diameter of the elastic esophageal body 103 isas the inner diameter max value of the lower esophageal sphincter so asto prevent from slipping into the stomach or up the pharynx and or forprevent gastric reflux to overtake the elastic esophageal body.

Optionally, as shown at 302, after the naso/orogastric tube 101 isdisposed in the esophagus, the pump assembly 105 is prepared for aprompt inflation, optionally with a pressure tank, of the elasticesophageal body 103.

Reference is now also made to FIG. 5, which is a schematic illustrationof an exemplary pump assembly 105 which is connected, via an airconducting tube 410, to the elastic esophageal body 103, according tosome embodiments of the present invention. Optionally, the pump assembly105 includes an air container 401, which may be referred to herein as apressure tank 401, a pressure sensor 402 for estimating the pressureimplemented on the elastic esophageal body 103 by esophagus, a valve403, such as a three ways valve, for diverting air from the air pressuretank 401 either to the elastic esophageal body 103 or outside thenaso/orogastric device 100, also used to deflate the Balloon, aninflation release valve 404 for controlling the pressure maintenanceinside 401 and for controlling the inflation of the Balloon. Optionally,the controller 106 controls the valves 403, 404 and the pump 405 andreceives data from the sensors 402, 406.

In use, for example in 302, the pump assembly 105 increases the pressurein the air container 401 optionally to achieve a predefined pressureaccording to the reading of the pressure sensor 406. The built pressureallows prompt inflation of the elastic esophageal body 103. Optionally,the valve 403 allows reducing the pressure in the elastic esophagealbody 103 so as to avoid creating esophageal ulcer.

When a reflux is identified, for example according to the identificationof a backflow as shown at 202-203, the elastic esophageal body 103 isinflated, for example by the air from the air container 401. As thepressure in the air container 401 is high, for example 300 mmHg or more,the elastic esophageal body 103 may be inflated in less than a second.

As shown at 303, this process depicted in blocks 301-302 and 202-203 maybe repeated as long as the naso/orogastric tube 101 is in the esophagus,for example during one or more tube feeding sessions.

Now, as shown at 304, the elastic esophageal body 103 is deflated beforethe naso/orogastric device 100 is extracted from the esophagus of thepatient. Optionally, the air is released by opening the valve 403, or byusing pump assembly 105 as suction pump for the Balloon deflation.

Reference is now made to FIG. 6 which is a schematic illustration of thenaso/orogastric device 100 depicted in FIG. 1, where an elastic stomachbody 701 is attached to the distal end of its naso/orogastric tube 101,according to some embodiments of the present invention. In use, thedistal end and the elastic stomach body 701 are placed in the stomach ofthe patient. The elastic stomach body 701 is connected, via an inflationtube, and optionally deflation tube, to the pumping assembly 105 and/orto another pump. In use, the elastic stomach body 701 is inflated in thestomach. In such a manner, the elastic stomach body 701 prevents fromthe naso/orogastric tube 101 to slide toward the pharynx. This preventsfrom the elastic esophageal body 103 to slide toward the Lower pharynx,a location in which it can block the trachea and choke the patient.

As described above, the naso/orogastric tube 101 may be anaso/orogastric feeding tube 101. In such an embodiment, the elasticstomach body 701 may be placed on top of one or more of the feedingapertures of the naso/orogastric tube 101. In use, the feeding aperturesare placed in the stomach so as to allow the feeding of the patient. Inuse, the elastic stomach body 701 is filled by the feeding contents, forexample feeding fluids. The feeding contents are accumulated in theelastic stomach body 701, increasing its volume so that its diameter islarger than the diameter of the lower esophageal sphincter. Optionally,the elastic stomach body 701 has one or more apertures through which thefeeding contents are released. The apertures are optionally widened withthe increase in the volume of the elastic stomach body 701. In such amanner, the elastic stomach body 701 is filled before the feedingcontents are released.

Optionally, the elastic stomach body 701, when full, is used as ananchor for the naso/orogastric feeding tube 101. The weight of thefilled elastic stomach body 701 limits the movement of thenaso/orogastric feeding tube 101 and prevents it from fold and/or beingbundled in the stomach, and if there are sensors in the stomach they aresubmerged within the stomach content. In such a manner, the fluidsensors 102 and elastic esophageal body 103 do not sink toward thestomach or up the esophagus and remain in the esophagus so as to allowproper functioning as described above.

According to some embodiments of the present invention, the elasticesophageal body 103 is inflated by a flexible air conducting tube islocated outside the lumen of the naso/orogastric tube 101, for exampleattached on the peripheral surface thereof. In such an embodiment, theperimeter of the naso/orogastric tube 101 may be reduced as it does nothave to contain a conducting lumen for conducting air for inflating theelastic esophageal body 103. It should be noted that as the elasticesophageal body 103 should be inflated relatively fast in order to blockthe backflow, the perimeter of the conducting lumen has to be relativelywide, for example having a diameter of more than 1 mm and therefore theextraction thereof from the naso/orogastric tube 101 has a substantialeffect on the perimeter of the naso/orogastric tube 101. For example,reference is now made to FIG. 7, which is a schematic illustration of anaso/orogastric tube 101 and a blowup of segment thereof that depicts anexternal air conducting tube 501 for inflating the elastic esophagealbody 103, according to some embodiments of the present invention. As theexternal air conducting tube 501 is used only when the elasticesophageal body 103 is inflated, namely a short period of no more thanfew seconds, it is mostly in an uninflated state, adding practicallynothing to the perimeter of the naso/orogastric tube 101. Optionally,the external air conducting tube 501 is made of a thin polymeric layer,optionally about 80 micron or less. Optionally, the external airconducting tube 501 is part of a sheath 502 which is put on thenaso/orogastric tube 101. It should be noted that the naso/orogastrictube 101 may contain an air extraction lumen for removing air from theelastic esophageal body 103. However, as such a lumen may be relativelythin, for example with a diameter of less than 1 mm, the perimeter ofthe naso/orogastric tube 101 may be relatively limited.

Reference is now made to FIG. 8 which is a schematic illustration of anaso/orogastric device 800, such as the naso/orogastric device 100depicted in FIG. 1, a plurality of wires of an exemplary positioningsensor 801 are placed along the naso/orogastric tube 101, according tosome embodiments of the present invention. In this naso/orogastricdevice 800, the positioning sensor 801 and the fluid sensor includewires which are threaded in the naso/orogastric tube 101, for example inchannels which are formed therein. For example, FIG. 9A is a crosssectional illustration of an exemplary naso/orogastric tube havingchannels 901 for positioning wires of positioning sensor 801 andchannels 902 for the wires of the fluid sensor 102, which areoptionally, as the wires of the positioning sensor 801, threaded alongthe naso/orogastric tube 101. FIG. 9B is a sectional schematicillustration depicting optional and exemplary dimensions of such anexemplary naso/orogastric tube. In order to allow the sensors 801, 102to detect changes in the intrabody surrounding, for example in theesophageal lumen, openings 904, 905, such as cuts, optionallylongitudinal, are formed in one or more locations along the channels,optionally in different heights. In use, for the wires of the fluidsensor 102, the openings 905 allow a direct contact with GI fluid in theesophageal lumen. The direct contact allows detecting impedance changebetween different segments of the naso/orogastric tube 101. Optionally,the wires of the fluid sensor 102 are immersed in the naso/orogastrictube 101 so that a direct contact is formed when the GI fluids pass viathe openings 905. For example, FIG. 9C depicts an exemplary immersedfluid sensor 102. In this example, a segment of a wire of the fluidsensor 102 remains in the channel, below the opening. In such a manner,the wires of the fluid sensor 102 are not affected and/or blocked by theinner walls of the esophagus, for example with the esophageal sphincter.

In use, for the wires of the positioning sensor 801, the openings 904allow a direct contact with inner walls of the esophagus, for examplewith the esophageal sphincter. The direct contact allows detectingimpedance level, impedance change, and/or movement around at one or moresegments of the naso/orogastric tube 101. Optionally, the positioningsensor 801 detects and monitors position as described in InternationalPatent Application No. WO2008/107872, Published on Sep. 12, 2008, whichis incorporated herein by reference. Optionally, the wires of thepositioning sensor 801 are extracted via the openings 904 to protrudeabove the surface of the naso/orogastric tube 101. In this example, asegment of a wire of the positioning sensor 801 is extracted, via theopening 904, from its channel. In another example, depicted in FIG. 9D,the wire is treaded via holes in the naso/orogastric tube 101. In such amanner, segments of the wire of the positioning sensor 801 are above thenaso/orogastric tube 101 and other segments are below thenaso/orogastric tube 101. In such a manner, a direct contact with theinner walls of the esophagus, for example with the esophageal sphincter,may be established.

Optionally, the wires of the positioning sensors 801 are used toposition the naso/orogastric tube 101 in the esophagus, for example asdescribed in International Patent Application No. WO2008/107872,published on Sep. 12, 2008, which is incorporated herein by reference.

According to some embodiments of the present invention, the wires of thepositioning sensor 801 are connected to and controlled by the controller106. Optionally, the controller 106 monitors changes in the positioningof the naso/orogastric tube 101 according to the reading of theimpedance in the wires positioning sensors 801. As each wire may beexposed by an opening that is formed on another height of thenaso/orogastric tube 101, a change in the impedance in each wireindicates that a contact is established with the lumens' wall, forexample at the esophageal sphincter. This allows estimating the locationof the naso/orogastric tube 101.

In such embodiments, the pressure inside the elastic esophageal body 103is adjusted according to changes in the positioning of thenaso/orogastric tube 101. Optionally, the position of thenaso/orogastric tube 101 is monitored to detect misplacement and/or anunwanted displacement. In such a manner, the controller 106 may instructthe pump assembly 105 to reduce the pressure inside the elasticesophageal body 103 when misplacement and/or an unwanted displacementare detected. This may be used as a safety mechanism that assure that ifthe patient tries to extract the naso/orogastric device 100, when theelastic esophageal body 103 is fully and/or semi inflated, the pressurein the elastic esophageal body 103 is reduced, optionally immediacy, forexample within less than a second.

As described above, the naso/orogastric tube 101 is set to conductcontent into the stomach lumen of a patient and air to the elasticesophageal body 103. In such an embodiment, the naso/orogastric tube 101includes both a first channel orifice 913 for conducting content, suchas feeding, and a second channel orifice 914 for conducting air to theelastic esophageal body 103.

Reference is now also made to FIGS. 10A and 10B which schematically anexemplary connector 920 that allows connecting the naso/orogastric tube101 to a feeding device and to a pump assembly and a controller, such as105 and 106, according to some embodiments of the present invention. Theconnector 920 has a first channel orifice 923 for connecting a feedingdevice for conducting content via the first channel 913 and a secondchannel orifice 924 for connecting the pump assembly 105 for conductingair via the second channel 914 and optionally for connecting thecontroller 106 to the sensors in channels 901 and 902.

Optionally, the second channel orifice 924 is connected to the channels901, 902 that accommodate the sensors 102, 801. In such a manner, thenaso/orogastric device 100 may be connected via the first channelorifice 923 to an existing feeding machine and via the second channelorifice 924 to a dedicated device having the controller 106 and the pumpassembly 105.

Optionally, in order to maintain the sterilization of the pump assembly105, cable which connected to the second channel orifice 924 includes afilter which filters air conducted via the air channel 914. In such anembodiment, if the elastic esophageal body 103 and/or the air channelwhich conducts air thereto are torn or perforated, GI fluids, germs, orother impurities are blocked from contaminating the pump assembly 105and/or a tube that connects the pump assembly 105 to the filter. Itshould be noted that such a cable allows using the pump assembly 105 fora number of patients without requiring redundant sterilizationprocesses. Optionally, in order to maintain the sterilization of thefeeding unit, filter that controls the direction of feeding via thefeeding channel 913. In such an embodiment, if the feeding channel 913is torn or perforated, GI fluids, germs, or other impurities are blockedfrom contaminating the feeding unit or a tube that connects the feedingunit to the filter.

Optionally, the caps 930, 931 are detachably connected to the exemplaryconnector 920. In FIGS. 10A and 10B, the caps 931, 930 are not connectedto the connector 920 but rather supported by a holding element 932, suchas a flexible band. By placing them in front of the orifices of theexemplary connector 920, sterilization is maintained.

It is expected that during the life of a patent maturing from thisapplication many relevant devices and methods will be developed and thescope of the term biological biocompatible material is intended toinclude all such new technologies a priori.

As used herein the term “about” refers to ±10%.

The terms “comprises”, “comprising”, “includes”, “including”, “having”and their conjugates mean “including but not limited to”. This termencompasses the terms “consisting of” and “consisting essentially of”.

The phrase “consisting essentially of” means that the composition ormethod may include additional ingredients and/or steps, but only if theadditional ingredients and/or steps do not materially alter the basicand novel characteristics of the claimed composition or method.

As used herein, the singular form “a”, “an” and “the” include pluralreferences unless the context clearly dictates otherwise. For example,the term “a compound” or “at least one compound” may include a pluralityof compounds, including mixtures thereof.

The word “exemplary” is used herein to mean “serving as an example,instance or illustration”. Any embodiment described as “exemplary” isnot necessarily to be construed as preferred or advantageous over otherembodiments and/or to exclude the incorporation of features from otherembodiments.

The word “optionally” is used herein to mean “is provided in someembodiments and not provided in other embodiments”. Any particularembodiment of the invention may include a plurality of “optional”features unless such features conflict.

Throughout this application, various embodiments of this invention maybe presented in a range format. It should be understood that thedescription in range format is merely for convenience and brevity andshould not be construed as an inflexible limitation on the scope of theinvention. Accordingly, the description of a range should be consideredto have specifically disclosed all the possible subranges as well asindividual numerical values within that range. For example, descriptionof a range such as from 1 to 6 should be considered to have specificallydisclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numberswithin that range, for example, 1, 2, 3, 4, 5, and 6. This appliesregardless of the breadth of the range.

Whenever a numerical range is indicated herein, it is meant to includeany cited numeral (fractional or integral) within the indicated range.The phrases “ranging/ranges between” a first indicate number and asecond indicate number and “ranging/ranges from” a first indicate number“to” a second indicate number are used herein interchangeably and aremeant to include the first and second indicated numbers and all thefractional and integral numerals therebetween.

As used herein the term “method” refers to manners, means, techniquesand procedures for accomplishing a given task including, but not limitedto, those manners, means, techniques and procedures either known to, orreadily developed from known manners, means, techniques and proceduresby practitioners of the chemical, pharmacological, biological,biochemical and medical arts.

As used herein, the term “treating” includes abrogating, substantiallyinhibiting, slowing or reversing the progression of a condition,substantially ameliorating clinical or aesthetical symptoms of acondition or substantially preventing the appearance of clinical oraesthetical symptoms of a condition.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable subcombination or as suitable in any other describedembodiment of the invention. Certain features described in the contextof various embodiments are not to be considered essential features ofthose embodiments, unless the embodiment is inoperative without thoseelements.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the spirit and broad scopeof the appended claims.

All publications, patents and patent applications mentioned in thisspecification are herein incorporated in their entirety by referenceinto the specification, to the same extent as if each individualpublication, patent or patent application was specifically andindividually indicated to be incorporated herein by reference. Inaddition, citation or identification of any reference in thisapplication shall not be construed as an admission that such referenceis available as prior art to the present invention. To the extent thatsection headings are used, they should not be construed as necessarilylimiting.

The invention claimed is:
 1. A naso/orogastric device having backflowblocking means and adapted to feed a patient, comprising: anaso/orogastric tube having a distal end and a feeding channel with atleast one feeding opening located in said distal end for conducting afeeding content and first and second recesses formed along at least onesegment of a lateral surface of said naso/orogastric tube, saidnaso/orogastric tube is sized and shaped for being disposed within theesophagus so that at least a distal end thereof is in the stomach lumenof a patient while said at least one segment being placed in theesophagus of said patient; at least one elastic esophageal body,positioned above said first and sec recesses along said naso/orogastrictube, having a pressure dependent volume; at least one impedance sensorlocated in said first and second recesses for sensing an impedance whilesaid feeding channel is used for feeding said patient via said at leastone feeding opening, said first recess is formed above said secondrecess, said first recess and said second recess are formed above saidat least one feeding opening; and a pressure regulator that regulates apressure within said at least one elastic esophageal body according tosaid impedance.
 2. The naso/orogastric device of claim 1, wherein saidnaso/orogastric tube have distal and proximal ends, said at least oneimpedance sensor senses a first impedance reading in proximity to saiddistal end and a second impedance reading between said distal end andsaid proximal end.
 3. The naso/orogastric device of claim 2, whereinsaid pressure regulator regulates said pressure according to differencebetween said first impedance reading and said second impedance reading.4. The naso/orogastric device of claim 3, wherein said first and secondimpedance readings are used for calculating impedance change readings.5. The naso/orogastric device of claim 3, wherein said pressureregulator regulates said pressure according to the timing of a firstdetection event of said first reading relative to a second detectionevent of said second reading.
 6. The naso/orogastric device of claim 1,wherein said at least one impedance sensor is adapted to detect lowimpedance around said at least one segment.
 7. The naso/orogastricdevice of claim 1, wherein said impedance change is indicative of acontent of fluid around said at least one impedance sensor.
 8. Thenaso/orogastric device of claim 1, further comprising an air conductingtube having a lumen for allowing said pressure regulator to change thepressure in said at least one elastic esophageal body, said airconducting tube being attached to a peripheral surface of said tube. 9.The naso/orogastric device of claim 8, wherein said air conducting tubeis made of a layer of biocompatible flexible polymer having a thicknessof less than 200 micron.
 10. The naso/orogastric device of claim 1,wherein said tube has a first lumen for delivering nutrients,microorganisms, water or medications into the stomach lumen and a secondlumen for at least one of inflating and deflating said at least oneelastic esophageal body.
 11. The naso/orogastric device of claim 1,wherein said at least one impedance sensor comprises a plurality ofelectrodes arranged in a circular fashion around said naso/orogastrictube.
 12. The naso/orogastric device of claim 1, further comprising apump assembly, controlled by said pressure regulator so as to regulatesaid pressure by inflating said at least one elastic esophageal body.13. The naso/orogastric device of claim 12, wherein said pump assemblycomprising an air pressure tank, said pump assembly increases the airpressure in said air pressure tank so as to expedite said inflation. 14.The naso/orogastric device of claim 12, wherein said at least oneelastic esophageal body comprises a plurality of balloons arranged oneafter the other along said naso/orogastric tube.
 15. The naso/orogastricdevice of claim 1, further comprising at least one positioning sensormounted along said naso/orogastric tube to measure a value of a volumearound said naso/orogastric tube and a controller that detects alocation of at least one portion of said naso/orogastric tube in theesophagus.
 16. The naso/orogastric device of claim 15, wherein said atleast one positioning sensor comprises a wire threaded in a sensorchannel along said naso/orogastric tube, said sensor channel having atleast one opening therealong.
 17. The naso/orogastric device of claim15, wherein a pressure assembly said regulates said pressure accordingto said location.
 18. The naso/orogastric device of claim 15, whereinsaid controller detects a movement according to a change in saidlocation; said pressure regulator reducing said pressure in response tosaid change.
 19. The naso/orogastric device of claim 1, furthercomprising a connection to a cable having a filter to adjust air flowfrom said pressure regulator.
 20. The naso/orogastric device of claim 1,wherein said at least one impedance sensor comprises a plurality ofwires threaded in a plurality of sensor channels along saidnaso/orogastric tube, each said sensor channel having at least oneopening therealong.
 21. A method of preventing reflux during at leastone of tube feeding and esophageal endoscopy of patient, comprising:disposing a naso/orogastric tube within the esophagus, saidnaso/orogastric tube having: a feeding channel having at least onefeeding opening located at a distal end of said naso/orogastric tube forconducting a feeding content, first and second recesses formed one abovethe other along at least one segment of a lateral surface of saidnaso/orogastric tube and above said at least one feeding opening, atleast one impedance sensor located in said first and second recesses andadapted to read impedance, and at least one elastic esophageal bodymounted on said naso/orogastric tube above said first and secondrecesses, wherein said naso/orogastric tube is disposed within theesophagus so that at least said distal end of said naso/orogastric tubeis in the stomach lumen of a patient while said at least one segment isin the esophagus of the patient; sensing impedance in said first andsecond recesses using said at least one impedance sensor while saidfeeding channel is used for feeding said patient via said at least onefeeding opening; detecting fluid in at least one region along theesophagus according to an analysis of said impedance; and regulating apressure within said at least one elastic esophageal body according tosaid detection; wherein said first and second recesses expose said atleast one impedance sensor to said fluid.
 22. The method of claim 21,wherein said regulating comprises increasing said pressure so as toblock said esophagus when said impedance is indicative of present ofgastric content in said first and second recesses.
 23. The method ofclaim 21, wherein said regulating comprises decreasing said pressurewhen said impedance is indicative of an absence of gastric content insaid first and second recesses.
 24. The method of claim 21, wherein saiddisposing comprises disposing an elastic stomach body within thestomach, around said distal end, said regulating comprises regulating anadditional pressure within said elastic stomach body in parallel and incorrespondence with said pressure so as to prevent from said at leastone elastic esophageal body from moving toward the pharynx of saidpatient.
 25. A naso/orogastric device having backflow blocking means andadapted to feed a patient, comprising: a naso/orogastric tube having adistal end and having: a feeding channel with at least one feedingopening formed at said distal end for delivering content into thestomach lumen of a patient, first and second recesses formed along atleast one segment of a lateral surface of said naso/orogastric tube saidfirst recess is formed above said second recess and said first andsecond recesses are formed above said at least one feeding opening, anadjustable structure located above said first and second recesses andhaving at least one state wider than the perimeter of saidnaso/orogastric tube, and at least one impedance sensor located in saidfirst and second recesses and adapted to sense impedance while saidfeeding channel is used for feeding said patient via said at least onefeeding opening; a controller adapted to control a pressure inside saidadjustable structure according to said impedance.
 26. Thenaso/orogastric device of claim 25, wherein said content comprises amember of a group consisting of: nutrients, microorganisms, water andmedications.
 27. A naso/orogastric device adapted to feed a patient,comprising: a naso/orogastric tube having: a distal end and a feedingchannel for conducting a feeding content via at least one feedingopening formed in said distal end, and first and second recesses whichare formed above one another and above said at least one feeding openingalong at least one segment of a lateral surface thereof and sized andshaped for being disposed within the esophagus so that at least a distalend thereof being in the stomach lumen of a patient while said at leastone segment being in the esophagus of said patient; at least oneimpedance sensor located in said first and second recesses to measureimpedance while said feeding channel is used for feeding said patientvia said at least one feeding opening; and a controller which monitorschanges in the positioning of said naso/orogastric tube according tosaid impedance.